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NCT01501656 · ClinicalTrials.gov registry record
Epigenetic Testing for Breast Cancer Risk Stratification
A clinical trial, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 158
- Enrollment target
NCT01501656: Completed study, sponsored by University of Texas Southwestern Medical Center.
NCT01501656 is a clinical trial that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 158 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01501656 has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 158 participants
- Enrollment target
Study Summary
Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular events in malignant transformation and is readily detectable in apparently normal benign breast epithelium adjacent to breast cancers. The investigators hypothesize that DNA methylation of certain genes occurs as a field change in benign breast tissue that is at high risk for malignant transformation, and as such, can be exploited for tissue-based breast cancer risk stratification. Additional work is required to identify new DNA methylation markers potentially useful for periareolar fine needle aspiration (RP-FNA)-based breast cancer risk stratification, to determine whether these markers are methylated more frequently in benign samples from women who develop breast cancer, to determine whether assessment of these markers is reproducible, to determine whether tamoxifen reduces DNA methylation, and to better understand the pattern of DNA methylation in benign samples from unselected healthy control populations. Each of these objectives contributes to advancement of a clinically useful RP-FNA-based breast cancer risk stratification test. In addition, identification of genes that are preferentially methylated in estrogen receptor (ER) negative breast cancer will provide clues to the underlying biology responsible for this aggressive form of breast cancer. This knowledge may lead to the discovery of the causes of ER negative breast cancer, approaches for recognizing women at increased risk for this type of breast cancer, and approaches for reducing this risk. This study seeks to identify patterns of DNA methylation in benign breast epithelial cells associated with an increased risk for breast cancer with a focus on ER negative breast cancer.
Primary Outcome
This objective assesses methylation of seven genes in 97 archival breast cancer samples.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-11 |
What the finished NCT01501656 record still lists
NCT01501656 is an observational study that tracks outcomes without assigning an intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01501656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01501656 about?
NCT01501656 is a clinical study titled "Epigenetic Testing for Breast Cancer Risk Stratification". Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular events in malignant transformation and is readily detectable in apparently normal benign breast epithelium adjacent to breast cancers. The investigators hypothesize that DNA methylation of certain genes occurs a...
What is the current status of trial NCT01501656?
This trial is currently completed. The enrollment target is 158 participants. The study started on 2012-05. Estimated completion is 2014-11.
Who is sponsoring clinical trial NCT01501656?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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